Registry for understanding BK virus in kidney transplant patients
Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients
This study is trying to understand how the immune system responds to BK virus infections in kidney transplant patients to see how different treatments can help manage the virus and prevent complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06538961 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of adaptive immunity in kidney transplant recipients who have been diagnosed with BK virus infection. It focuses on understanding the immune responses, particularly the role of T cells, in managing BK viremia and the impact of various treatment approaches, including immunosuppression reduction and intravenous immunoglobulins. The study will collect blood and urine samples from participants to analyze their immune responses and identify those at higher risk for developing complications related to BK virus infection. The cohort will primarily consist of high immunological risk kidney transplant recipients, including retransplant candidates and those with a history of desensitization therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are adult kidney transplant recipients diagnosed with BK viremia.
Not a fit: Patients who have undergone multi-organ transplants or are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for BK virus infection in kidney transplant recipients, potentially reducing complications and improving transplant outcomes.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated the importance of T cell responses in managing viral infections in transplant recipients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (\>18 years old) male and female, deceased donor KT recipients * Will include single organ transplants. * Each participant must also have recently been diagnosed with BK viremia. * In addition to the aforementioned inclusion criteria, each participant in the sub-study must also have recently been diagnosed with BK viremia or have difficult-to-treat BKV \> 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab). Exclusion Criteria: * Prisoners will not be included in the study * Multi-organ transplants and pregnant women
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Ambreen Azhar — Virginia Commonwealth University
- Study coordinator: Ambreen Azhar
- Email: ambreen.azhar@vcuhealth.org
- Phone: 804-828-4104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.